NCT00065234

Brief Summary

The purpose of this study is to determine if acupuncture is effective in preventing prolonged postoperative paralysis of the gastrointestinal tract among patients undergoing colostomy/ileostomy closure.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2003

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2003

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

First QC Date

July 18, 2003

Last Update Submit

March 27, 2017

Conditions

Keywords

ColostomyIleostomy

Interventions

AcupuncturePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous surgical cancer treatment with ileostomy/colostomy, now scheduled for closure
  • Hospital admission must be same day as surgery

You may not qualify if:

  • Incapacitating disease
  • Concurrent herbal or laxative use
  • Use of Heparin or Coumadin
  • Upper or lower extremity deformities
  • Chronic constipation prior to cancer diagnosis
  • History of cerebrovascular accident or spinal cord injury
  • Chronic pain that has been treated with any form of major opioid or weak opioids (=/\> 30mg/24 hours)
  • Pacemaker or metal implants
  • Concurrent alternative medicine/herbal use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

IleusNeoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Joseph S Chiang, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 18, 2003

First Posted

July 22, 2003

Study Start

September 1, 2003

Study Completion

May 1, 2006

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations